FDA.reportPublic FDA data

D-104

Product NDC
58264-0110
11-digit product format
582640110
Labeler code
58264
Product ID
58264-0110_2b9ed194-def5-363e-e063-6294a90a8cdc
Type
HUMAN OTC DRUG
Nonproprietary name
Apium graveolens whole, Asclepias incarnata root, Calcium arsenate, Camphor (Natural), Echinacea angustifolia, Eupatorium perfoliatum flowering top, Euphrasia stricta, Ferrous iodide, Ichthammol, Scabies Lesion Lysate (Human), Thuja occidentalis leafy twig, and Trifolium repens flower
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
APIUM GRAVEOLENS WHOLE; ASCLEPIAS INCARNATA ROOT; CALCIUM ARSENATE; CAMPHOR (NATURAL); ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; FERROUS IODIDE; ICHTHAMMOL; SCABIES LESION LYSATE (HUMAN); THUJA OCCIDENTALIS LEAFY TWIG; TRIFOLIUM REPENS FLOWER
Active strength
6; 4; 12; 12; 4; 6; 6; 6; 12; 30; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
D-104
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIUM GRAVEOLENS WHOLE6 [hp_X]/mL
ASCLEPIAS INCARNATA ROOT4 [hp_X]/mL
CALCIUM ARSENATE12 [hp_X]/mL
CAMPHOR (NATURAL)12 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA4 [hp_X]/mL
EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]/mL
EUPHRASIA STRICTA6 [hp_X]/mL
FERROUS IODIDE6 [hp_X]/mL
ICHTHAMMOL12 [hp_X]/mL
SCABIES LESION LYSATE (HUMAN)30 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG6 [hp_X]/mL
TRIFOLIUM REPENS FLOWER4 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15V0BLB71G, 4N9UU1HQKG, 95OX15I8ZU, N20HL7Q941, VB06AV5US8, 1W0775VX6E, C9642I91WL, F5452U54PN, NQ14646378, 5UAU16Z1U4, 1NT28V9397, 49Y788T742

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0110-12022-06-06C16284748780-19d75b9d0-9112-f424-e053-dadaa90a57ceD-104
58264-0110-12020-01-31C16284748780-19d75b9d0-9112-f424-e053-dadaa90a57ceD-104

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0110-1D-10429.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0110D-104 (APIUM GRAVEOLENS WHOLE, ASCLEPIAS INCARNATA ROOT, CALCIUM ARSENATE, CAMPHOR (NATURAL), ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, FERROUS IODIDE, ICHTHAMMOL, SCABIES LESION LYSATE (HUMAN), THUJA OCCIDENTALIS LEAFY TWIG, AND TRIFOLIUM REPENS FLOWER) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_09c3912a-71ba-4814-8b91-d0e787b542bf.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0110-15826401100129.57 mL in 1 BOTTLE, GLASS (58264-0110-1) 29.57 ml1990-01-010000-00-00NoNoCurrent